TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR— 510(k) K896825

Name: FDA 510(k) clearance K896825
Creator: U.S. Food and Drug Administration
Published: 1990-11-16

Substantially Equivalent

Infrasonics Corp.

FDA 510(k) clearance K896825 for TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR, Substantially Equivalent on 1990-11-16. Applicant: Infrasonics Corp.. Device class: 2.

Clearance details

Applicant: Infrasonics Corp.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1989-12-05
Decision date: 1990-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland Park, FL, US

Download summary PDF View on FDA.gov ↗

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